Journal de recherche clinique et expérimentale en dermatologie
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Quality of Life for Patients with Advanced Basal Cell Carcinoma Treated with Hedgehog Signaling Pathway Inhibitors

Michael R. Migden

Basal cell carcinoma (BCC), the most common form of cancer, affects approximately 2 million people annually in the US. Aberrant activation of the hedgehog signaling pathway plays an important role in BCC. Two inhibitors of the SMO component of hedgehog signaling, vismodegib and sonidegib, are currently approved for use in advanced BCC, including locally advanced BCC (laBCC) and metastatic BCC (mBCC), depending on the country of approval. Location of lesions and fears about changes in appearance may affect the quality of life (QoL) of patients with advanced BCC. In addition, QoL itself is an outcome for advanced BCC. The key clinical trials for vismodegib (ERIVANCE and STEVIE) and for sonidegib (BOLT) included QoL as secondary end points, using different questionnaires for assessment. In ERIVANCE, Short Form-36 for assessing QoL showed no changes from baseline on either the physical or emotional domains. In STEVIE, the Skindex-16 for assessing QoL showed that treatment with vismodegib was associated with clinically meaningful improvement in the emotional domain. To determine QoL, BOLT used predetermined subscales related to skin specifically from the European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30 and the EORTC H&N35. Both the QLQ-C30 and H&N35 selected subscales showed either maintenance or improvement from baseline. Factors affecting QoL during treatment of patients with advanced BCC include baseline QoL, having fewer comorbidites, and having better initial mental health status. In addition, patients whose lesions were advanced, but were not as large as others or not located in visible areas (ie, head and neck) reported better QoL. Treatment-emergent adverse events (AEs) have an impact on QoL in patients with advanced BCC. Most of the AEs reported in trials for vismodegib and sonidegib were grade 1-2. Using techniques to manage AEs effectively may help improve QoL for those whose QoL decreases during treatment.